Exercise in Men With Prostate Cancer
A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 2, 2009
CompletedFirst Posted
Study publicly available on registry
February 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 1, 2011
January 1, 2011
2.2 years
February 2, 2009
January 31, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
bone health
baseline, 12 months
Study Arms (2)
Control
NO INTERVENTIONExercise
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- men aged 50 years or older
- diagnosed with adenocarcinoma prostate cancer
- will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment
- Patients will also consent to participating in the study.
You may not qualify if:
- severe cardiac disease (New York Heart Association class III or greater)
- angina
- severe osteoporosis
- uncontrolled hypertension (blood pressure \> 160/95mm Hg)
- orthostatic blood pressure drop \> 20mm Hg
- moderate to severe aortic stenosis
- acute illness or fever
- uncontrolled atrial or ventricular dysrhythmias
- uncontrolled sinus tachycardia (\> 120 beats per minute)
- uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (\> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, pathological lower limb fractures within 6 months, lower limb amputation).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Manitoba Medical Service Foundationcollaborator
Study Sites (1)
University of Manitoba
Winnipeg, Manitoba, R3E 0T6, Canada
Related Publications (1)
Lee CE, Leslie WD, Lau YK. A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy. BMC Cancer. 2012 Mar 21;12:103. doi: 10.1186/1471-2407-12-103.
PMID: 22436542DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C. Ellen Lee, PhD, PT
University of Manitoba
- PRINCIPAL INVESTIGATOR
Y.K. James Lau, MD, PhD
CancerCare Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 2, 2009
First Posted
February 3, 2009
Study Start
October 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 1, 2011
Record last verified: 2011-01